Cannabidiol for Treating PTSD symptoms and Neurocognitive Impairment in PTSD and PTSD Comorbid with TBI: A Placebo-controlled RCT with Neural-circuit centered Precision Medicine Prediction of Response.
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Traumatic Brain InjuryPost Traumatic Stress Disorder
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Age: Between 18 Year(s) - 85 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- DSM-5 current diagnosis of PTSD with the Clinician Administered PTSD Scale (CAPS-5)
- TBI present (for PTSD+TBI subjects only)
- Mild TBI (for PTSD+TBI subjects only)
- Able to provide at least 2 locators (contacts)
- Able to provide voluntary written informed consent
- Participants who are reliably domiciled
- Agreement to abstain from all other cannabinoid use for the duration of the study
- Willingness to use contraception if male or female of childbearing potential.
You may not be eligible for this study if the following are true:
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- History of open head injury
- TBI within the last 6 months
- Moderate-severe TBI
- SUD in the last 6 months other than mild AUD or nicotine use
- Use of any cannabinoid containing product within the last 1 month
- Positive urine drug screen
- Currently prescribed medications with possible CBD-drug interactions
- Exposure to trauma in the last 30 days, including police duty or military service
- Psychotherapy for PTSD or other psychiatric conditions if initiated within 2 months of screening
- Not stable for at least 2 months on psychiatric medication, anticonvulsants, antihypertensive medication, sympathomimetic medication, estrogen replacement therapy, medications associated with neurogenesis, or steroid medication
- Active suicide attempt within the past year
- Current significant suicidality (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months
- Neurologic disorder or systemic illness affecting CNS function (apart from TBI)
- Major medical illness
- Clinical diagnosis of anemia
- Significant laboratory abnormalities
- Significant allergic reactions to the drug including cannabinoids or sesame oil
- Those pregnant or lactating
- Contraindication to MRI
- Males and females who plan to conceive a child during or two weeks following the study
- Active legal problems likely to result in incarceration within 12 weeks of treatment initiation
- Has a high risk of adverse emotional or behavioral reaction
- Inpatient psych treatment in past 12 months
- Active military
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.